What is the key difference between a 'signal' and a 'confirmed safety concern' in pharmacovigilance?
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A
A signal is from spontaneous reports; a safety concern is from clinical trials only
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B
A signal is an unverified hypothesis of a drug-event association; a confirmed concern has sufficient evidence to require action
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C
A signal requires a case series; a safety concern requires an epidemiological study
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D
There is no meaningful difference — the terms are interchangeable